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FDA BLA · BLA761029

ZINBRYTA

Sponsor: BIOGEN

APPLICATION
BLA761029
TYPE
BLA
ORIGINAL APPROVAL
2016-05-27
LATEST ACTION
2017-11-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZINBRYTAPrescription
DACLIZUMAB 150MG/ML · INJECTABLE · INJECTION

Approval history

2017-11-01REMS · Supplement 5 — Letter ↗AP
2017-08-28Labeling · Supplement 7 · standard — Label ↗AP
2017-08-28Labeling · Supplement 2 · standard — Label ↗AP
2017-05-26Efficacy · Supplement 1 · standard — Label ↗AP
2016-05-27Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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